MAUDE Adverse Event Report: EDWARDS LIFESCIENCES TRANSLUMINAL BIPOLAR PACING PROBE; ELECTRODE, PACEMAKER, TEMPORARY

Model Number PE074F5

Device Problem Pacing Problem (1439)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2022

Event Type  malfunction  

Event Description

It was reported that the pacing waveform of a swan ganz was not displayed on the monitor and was unable to pace from the beginning of use after the catheter insertion in the catheter laboratory at night emergency unit.The catheter was inserted to the patient with sick sinus syndrome for temporary pacing before implanting a pacemaker.The issue was resolved by replacing the catheter.The patient initials are (b)(6), age: 85, weight: 56kg and gender: female.The device was discarded at the hospital.There were no patient complications reported.

Manufacturer Narrative

The device was not returned for evaluation.Device was discarded at hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.Further evaluation regarding supplier related quality issues is under investigation.A device history record review was completed and documented that device met all specifications upon distribution.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.

• Brand Name: TRANSLUMINAL BIPOLAR PACING PROBE
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 14788099
• MDR Text Key: 302926072
• Report Number: 2015691-2022-06345
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K813521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/16/2023
• Device Model Number: PE074F5
• Device Lot Number: 63967870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 56 KG